Senior Project Manager (Pharmacovigilance) - Remote

Overview

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

In Short

• Serve as the Lead on Client programs for pharmacovigilance activities.
• Manage daily interactions with Clients, Sponsors, and staff.
• Assist in developing project-specific safety plans and guidelines.
• Ensure data is maintained in the safety database system.
• Manage communications regarding safety issues.
• Participate in training sessions and workshops.
• Monitor compliance metrics and project budgets.
• Ensure adherence to regulations and timelines.
• Maintain Pharmacovigilance files for assigned projects.
• Work under the direction of the Associate Director of Client Services.

Requirements

• Experience in Pharmacovigilance is mandatory.
• Strong project management skills.
• Knowledge of ICH/GCP guidelines.
• Excellent communication skills.
• Ability to work collaboratively with clients and teams.
• Experience with safety database systems.
• Strong analytical and problem-solving skills.
• Ability to monitor compliance metrics.
• Experience in developing safety plans and documentation.
• Ability to manage project budgets effectively.

Benefits

• Opportunity to work in a rapidly growing company.
• Engagement in diverse and challenging projects.
• Work with a dynamic and consultative team.
• Access to training and professional development.
• Competitive salary and benefits package.
• Potential for career advancement.
• Contribute to important pharmaceutical services.
• Flexible working environment.
• Global exposure and collaboration.
• Supportive company culture.